Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee

G

Grünenthal

Status and phase

Active, not recruiting
Phase 3

Conditions

Osteoarthritis

Treatments

Drug: RTX-GRT7039
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05449132
KF7039-02
2021-005020-38 (EudraCT Number)
U1111-1268-7267 (Other Identifier)

Details and patient eligibility

About

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Full description

This trial comprises a total observation period of up to 52 weeks.

Enrollment

450 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The participant has given written informed consent to participate.
  • The participant is 18 years of age or older at the Screening Visit.
  • The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
  • There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.

Exclusion criteria

  • The participant has past joint replacement surgery of the index knee.
  • The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
  • The participant has periarticular pain from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis.
  • The participant has clinical hip osteoarthritis on the side of the index knee.
  • The participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (RPOA) Type I or Type II.
  • The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus >10, valgus >10) by X-ray as assessed by independent Central Readers at Screening Visit.
  • The participant has other conditions that could affect trial endpoint assessments of the index knee.
  • The participant has current clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the participant's participation in the full duration of the trial.
  • The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
  • The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
  • The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

450 participants in 2 patient groups, including a placebo group

RTX-GRT7039
Experimental group
Description:
Participants will receive a single intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.
Treatment:
Drug: RTX-GRT7039
Placebo
Placebo Comparator group
Description:
Participants will receive a single intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.
Treatment:
Drug: Placebo

Trial contacts and locations

81

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Central trial contact

Director clinical trials

Data sourced from clinicaltrials.gov

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